Effect and Mechanism of Jiajian Guishen Formulation on Premature Ovarian Insufficiency Based on Metabolomics

NCT06102655 | Completed Early Phase 1

• 2 other identifiers: 2023DZMEC-2902023DZMEC-290-02
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Identify differential metabolites in POI patients.
2. 2.Analysis of differential metabolites and their involved mechanism pathways.

Conditions

Premature Ovarian Insufficiency; Metabolomics; Traditional Chinese Medicine; Mechanism; Clinical Syndrome

Keywords

Premature Ovarian Insufficiency; Metabolomics; Traditional Chinese Medicine; Mechanism; Clinical Syndrome

Outcome Measures

Primary Outcomes (1)

• follicle stimulating hormone,FSH

  Blood samples are collected before and after treatment.

  On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

Secondary Outcomes (15)

• anti mullerian hormone, AMH

  On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

• Evaluation of the efficacy of Traditional Chinese Medicine symptoms

  before and1 month after the treatment

• Improved Kupperman Scale Scoring

  before and 1 month after the treatment

• estradiol, E2

  On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

• luteinizing hormone, LH

  On the 2~4th day of menstruation (amenorrhea patients before and after taking medication)

Study Arms (2)

treatment group（Jiajian Guishen Formulation）

EXPERIMENTAL

Jiajian Guishen Formulation is a traditional Chinese medicine, it will be used in POI patients for three menstrual cycles; their blood samples are collected before and after treatment.

Drug: Jiajian Guishen Formulation

no-treatment control group

NO INTERVENTION

healthy people

Interventions

Jiajian Guishen Formulation DRUG

Jiajian Guishen Formulation is a formulation of Traditional Chinese Medicine.POI patients will be treat with Jiajian Guishen Formulation for three menstrual cycles; their blood samples are collected before and after treatment.No drug will be used in control group, and their blood samples are collected when join the experiment.

treatment group（Jiajian Guishen Formulation）

Eligibility Criteria

• Age: 18 Years - 39 Years
• Gender Eligibility Details: biological
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed by Western medicine with premature ovarian insufficiency;
• Patients with Chinese medicine differentiation of kidney deficiency and liver depression;
• ≤ patients' age ≤ 39 years;
• Patients who do not use other drugs during treatment;
• Patients who voluntarily participate in this study, sign an informed consent form, and agree to take the corresponding treatment plan.
• The above five items must be met to be included in the POI patient group in this study.
• ≤ Age≤ 39 years old;
• menstrual regularity;
• There is no abnormality in sex hormone and AMH examination;
• Voluntarily participate in this research and sign the informed consent form;
• Those who match the general information such as age, height, and weight of the patients included in POI.

You may not qualify if:

• Patients with congenital gonadal dysplasia or a family history similar to "early menopause";
• POI patients with acquired organic lesions or ovarian surgery;
• Patients who have taken Western medicine artificial cycle therapy or other endocrine therapy in the past three months;
• Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system;
• Patients who are breastfeeding or pregnant;
• Patients who are allergic to the drugs used in this study or have a history of previous allergy to traditional Chinese medicines.
• Those who met any of the above 5 criteria were excluded from this study. Healthy subjects were excluded as (1), (3), (4), (5).

Sponsors & Collaborators

• Shi Yun: lead

Study Sites (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, China

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Yun Shi

  Dongzhimen Hospital of Beijing University of Chinese Medicine

  STUDY DIRECTOR

• Ke Xu, Master

  Dongzhimen Hospital of Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Jing yi Shao, Master

  Dongzhimen Hospital of Beijing University of Chinese Medicine

  STUDY CHAIR

• Xi yu Li, Bachelor

  Dongzhimen Hospital of Beijing University of Chinese Medicine

  STUDY CHAIR

• Qin yang Liu, Bachelor

  Dongzhimen Hospital of Beijing University of Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 26, 2023
• Study Start: July 24, 2023
• Primary Completion: July 20, 2024
• Study Completion: July 20, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)